Ibandronic acid Viatris 150 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Ibandronic Acid Viatris 150 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Ibandronic Acid Viatris is and what it is used for
2. What you need to know before taking Ibandronic Acid Viatris
3. How to take Ibandronic Acid Viatris
4. Possible side effects
5. How to store Ibandronic Acid Viatris
6. Contents of the pack and other information

1. What is Ibandronic Acid Viatris and what is it used for

Ibandronic Acid Viatris belongs to a group of medicines called bisphosphonates, and contains the active substance ibandronic acid.

Ibandronic Acid Viatris can reverse bone loss, as it prevents further bone loss and increases bone mass in most women who take it, even if they are unable to see or feel the difference. Ibandronic Acid Viatris can help reduce the occurrence of bone breaks (fractures). This reduction has been demonstrated for vertebral fractures, but not for hip fractures.

Your doctor has prescribed Ibandronic Acid Viatris to treat your postmenopausal osteoporosis because you have a high risk of fractures. Osteoporosis is a condition characterized by thinning and weakening of the bones, which is common among women after menopause. During menopause, the ovaries stop producing the female hormone estrogen, which helps maintain skeletal health.

The earlier a woman reaches menopause, the greater her risk of fractures due to osteoporosis.

Other factors that increase the risk of fractures include:

• Inadequate dietary intake of calcium and vitamin D.
• Smoking or excessive alcohol consumption.
• Lack of walking or other weight-bearing exercises.
• Family history of osteoporosis.

Healthy lifestyle habits also support the beneficial effects of treatment. These include:

• A balanced diet rich in calcium and vitamin D.
• Walking or any other weight-bearing exercise.

Do not smoke and avoid excessive alcohol consumption.

2. What you need to know before starting to take Ibandronic Acid Viatris

Do not take Ibandronic Acid Viatris:

• If you are allergic to ibandronic acid or to any of the other ingredients of this medicine (listed in section 6).
• If you have certain problems in the throat/digestive tract (oesophagus), such as narrowing or difficulty swallowing.
• If you cannot remain upright, either standing or sitting, for at least one continuous hour (60 minutes).
• If you have or have had low levels of calcium in your blood. Please consult your doctor.

Warnings and precautions

Very rarely, an adverse reaction called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported during post-marketing experience in patients treated with ibandronic acid for osteoporosis. ONJ may also occur after stopping treatment.

It is important to try to prevent the development of ONJ, as it is a painful condition that may be difficult to treat. To reduce the risk of developing mandibular osteonecrosis, certain precautions should be taken.

Atypical fractures of long bones, such as the forearm bone (ulna) and shin bone (tibia), have also been reported in patients receiving long-term treatment with ibandronate. These fractures occur following minimal or no trauma, and some patients experience pain in the area of the fracture prior to a complete fracture occurring.

Before starting treatment, inform your doctor/nurse (healthcare professional) if:

• You have mouth or dental problems, such as poor dental health, gum disease, or planned tooth extraction.
• You do not receive routine dental care or have not had a dental check-up for a long time.
• You are a smoker (as this may increase the risk of dental problems).
• You have previously been treated with a bisphosphonate (used to treat or prevent bone disorders).
• You are taking medicines called corticosteroids (such as prednisolone or dexamethasone).
• You have cancer.

Your doctor may ask you to undergo a dental examination before starting treatment with ibandronic acid.

While on treatment, you should maintain good oral hygiene (including regular tooth brushing) and undergo routine dental check-ups. If you wear dentures, ensure they are properly fitted. If you are undergoing dental treatment or are scheduled for dental surgery (e.g., tooth extraction), inform your doctor about your dental treatment and inform your dentist that you are being treated with ibandronic acid.

Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth, such as tooth loss, pain or swelling, or difficulty healing of ulcers or discharge, as these may be signs of osteonecrosis of the jaw.

Some people require special care during treatment with ibandronic acid. Consult your doctor or pharmacist before starting Ibandronic Acid Viatris:

• If you have a mineral metabolism disorder (e.g., vitamin D deficiency).
• If you have kidney problems.
• If you have difficulty swallowing or digestive problems.

Irritation, inflammation, or ulceration of the throat/digestive tract (oesophagus) may occur, often with symptoms such as severe chest pain, severe pain after swallowing food and/or drink, severe nausea or vomiting, especially if patients do not drink a full glass of water and/or lie down before one hour has passed after taking ibandronic acid. If you develop these symptoms, stop taking ibandronic acid and inform your doctor immediately (see section 3).

Children and adolescents

Do not give ibandronic acid to children or adolescents under 18 years of age.

Other medicines and Ibandronic Acid Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Especially:

• Supplements containing calcium, magnesium, iron, or aluminium, as they may interfere with the effects of ibandronic acid.
• Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) (such as ibuprofen, sodium diclofenac, and naproxen) may irritate the stomach and intestines. Bisphosphonates (such as ibandronic acid) may also do so. Therefore, be very careful when taking painkillers or anti-inflammatory medicines at the same time as ibandronic acid.

After taking the monthly Ibandronic Acid Viatris tablet, wait 1 hour before taking any other medicine, including indigestion tablets, calcium supplements, or vitamins.

Taking Ibandronic Acid Viatris with food and drink

Do not take Ibandronic Acid Viatris with food. Ibandronic acid becomes less effective if taken with food. You may drink water, but no other liquids.

After taking Ibandronic Acid Viatris, wait 1 hour before eating any food or drinking anything (see section 3, How to take Ibandronic Acid Viatris).

Pregnancy and breastfeeding

Ibandronic acid is intended for use only in postmenopausal women and should not be taken by women of childbearing age.

Do not take ibandronic acid if you are pregnant or breastfeeding.

Consult your doctor or pharmacist before taking this medicine.

Driving and using machines

You may drive and use machines, as ibandronic acid has no effect or a negligible effect on your ability to drive and use machines.

Ibandronic Acid Viatris contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Ibandronic Acid Viatris

Follow exactly the instructions for taking this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

The usual dose of Ibandronic Acid Viatris is one tablet per month.

How to take the monthly tablet

It is important that you carefully follow these instructions. They are designed to ensure that the Ibandronic Acid Viatris tablet reaches the stomach quickly and causes less irritation.

• Take one 150 mg Ibandronic Acid Viatris tablet once a month.

• Choose a day of the month that is easiest for you to remember. You may choose the same date (such as the first day of each month) or the same day of the week (such as the first Sunday of each month) to take the Ibandronic Acid Viatris tablet. Choose whichever best fits your routine.

• Take the Ibandronic Acid Viatris tablet after at least 6 hours without food or drink (except water).

• Take the Ibandronic Acid Viatris tablet

• immediately upon waking up, and

• before breakfast or drinking any liquids (on an empty stomach).

• Swallow the tablet with a full glass of water (at least 180 ml).

• Do not take the tablet with water that has a high calcium content, fruit juice, or other beverages. If you are unsure about potentially high calcium levels in tap water (hard water), it is recommended to use bottled water with low mineral content.

• Swallow the tablet whole – do not chew, crush, or allow it to dissolve in your mouth.

• During the hour following tablet ingestion (60 minutes)

• Do not lie down; if you do not remain upright (standing or sitting), part of the medicine may return to the esophagus.

• Do not eat anything.

• Do not drink anything (except water, if needed).

• Do not take any other medication.

• After waiting one hour, you may eat breakfast and drink your first beverage of the day. Once you have eaten, you may lie down and take any other medications you require.

• Do not take this medicine at bedtime or before getting up.

Continuation of treatment with Ibandronic Acid Viatris

It is important that you take Ibandronic Acid Viatris every month, as directed by your doctor. After 3–5 years of taking Ibandronic Acid Viatris, consult your doctor to determine whether you should continue treatment.

If you take more Ibandronic Acid Viatris than you should

If you accidentally take extra tablets, drink a full glass of milk and contact your doctor immediately.

Do not induce vomiting or lie down, as Ibandronic Acid Viatris could irritate your esophagus.

If you forget to take Ibandronic Acid Viatris

• If you forget to take the tablet on the morning of your chosen day, do not take the tablet later in the day.

Instead, check your calendar to determine when your next dose is due.

• If you forgot to take the tablet on your chosen day and your next dose is due within 1 to 7 days:

Never take two Ibandronic Acid Viatris tablets within the same week. Wait until your next scheduled dose and take it as usual, then continue taking one tablet per month according to the dates marked on your calendar.

• If you forgot to take the tablet on your chosen day and your next dose is due in more than 7 days:

Take one tablet on the morning after the day you remember missing the dose, then resume taking one tablet per month according to the dates marked on your calendar.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Tell your doctor or nurse immediately if you notice any of the following serious adverse effects, as you may need urgent medical treatment:

Uncommon (may affect up to 1 in 100 people):

• Severe chest pain, severe pain when swallowing food or drink, severe nausea or vomiting, difficulty swallowing. You may have inflammation of the throat/digestive tract, possibly with sores or narrowing of the throat/digestive tract (oesophagus).
• Symptoms of low calcium levels in the blood (hypocalcaemia) including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth.

Rare (may affect up to 1 in 1,000 people):

• Itching, swelling of the face, lips, tongue and throat, with difficulty breathing.
• Persistent eye pain and inflammation.
• New pain, weakness or discomfort in the thigh, hip or groin. You may be experiencing early signs of an unusual femur fracture.

Very rare (may affect up to 1 in 10,000 people):

• Pain or sensation of pain in the mouth or jaw. You may be experiencing early signs of serious jaw problems: necrosis (death of bone tissue) of the jaw bone.
• Consult your doctor if you have ear pain, discharge from the ear, or suffer an ear infection. These could be symptoms of damage to the ear bones.
• Severe skin reactions, including a red, itchy rash, blisters or skin peeling.
• Severe allergic reaction, which may be life-threatening.

Other possible adverse effects

Common (may affect up to 1 in 10 people):

• Headache.
• Heartburn, discomfort when swallowing, stomach pain or abdominal pain (may be due to stomach inflammation), indigestion, nausea, diarrhoea (loose stools).
• Muscle cramps, stiffness in joints and limbs.
• Flu-like symptoms, including fever, chills and shivering, feeling unwell, bone, muscle and joint pain. Consult your doctor or nurse if any of these effects become troublesome or last more than a few days.
• Skin rash.

Uncommon (may affect up to 1 in 100 people):

• Dizziness.
• Flatulence (gas, bloated feeling).
• Back pain.
• Feeling tired or exhausted.
• Asthma attacks.

Rare (may affect up to 1 in 1,000 people):

• Inflammation of the duodenum (the first part of the intestine) causing stomach pain.
• Urticaria.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibandronic Acid Viatris

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the container after "EXP". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Ibandronic Acid Viatris

The active substance is ibandronic acid 150 mg (as sodium monohydrate).

The other components are:

• Tablet core: lactose monohydrate, povidone (E1201), microcrystalline cellulose (E460), crospovidone (E1202), colloidal anhydrous silica, and magnesium stearate (E470b).

• Tablet coating: hydroxypropylcellulose (E463), macrogol, and titanium dioxide (E171).

• The printing ink contains shellac, iron oxide black, and propylene glycol.

Appearance of Ibandronic Acid Viatris and contents of the container

Film-coated tablets, white in color, capsule-shaped and biconvex, with "G" above "I-150" printed in black ink on one side and plain on the other.

Ibandronic Acid Viatris is available in packs of 1, 3, 6, and 12 tablets. Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer:

McDermott Laboratories Ltd. t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road
Dublin – 13
Ireland

or

Mylan Hungary Kft.
Mylan utca 1
H-2900 Komárom
Hungary

For further information about this medicine, contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Denmark: Ibandronic Acid Mylan
Slovakia: Ibandronic Acid Viatris 150 mg
Spain: Ácido Ibandrónico Viatris 150 mg film-coated tablets EFG
Ireland: Ibandronic Acid Viatris 150 mg
Italy: Acido Ibandronico Mylan 150 mg
Malta: Ibandronic Acid Mylan 150 mg
Netherlands: Ibandroninezuur Viatris 150 mg
Poland: Ibandronic Acid Viatris
Portugal: Ácido ibandrónico Mylan 150 mg
United Kingdom: Ibandronic Acid Mylan 150 mg
Czech Republic: Ibandronic Acid Viatris 150 mg Film-coated Tablets

Date of the most recent review of this leaflet: May 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): https://www.aemps.gob.es/